Question

1. Describe the Pharmacovigilance system.

2. Who are the key stakeholders in pharmacovigilance system?

3.Give the responsibility and function of stakeholders.

4. Enumerate the guidelines of good pharmacovigilance practice.

5. What is the correlation between pharmacovigilance and antimicrobial stewardship program?

Answer 1

1•The Detailed Description of Pharmacovigilance System (DDPS) is an important part of monitoring veterinary medicinal products. Pharmacovigilance is the monitoring of adverse events and suspected adverse events.   

A DDPS is an obligatory part of the scientific dossier that you as a marketing authorisation holder submit in order to obtain marketing authorisation for a veterinary medicinal product.

In a DDPS you give a detailed description of your pharmacovigilance system and demonstrate that you are competent to collect and evaluate reports of adverse events in the correct manner. You also indicate that you have a QPPV (Qualified Person PharmacoVigilance). This is a person within your company who is responsible for the correct processing of all pharmacovigilance data.

2•​​​​The key stakeholders involved in the Adverse Drug Reaction & medicine usage are Doctors, Pharmacists, Nurses and Patients.

3•Stakeholders have legal decision-making rights and may control project scheduling and budgetary issues. Most project stakeholders have responsibilities businesses that include educating developers, financing projects, creating scheduling parameters and setting milestone dates.

4•Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level. The guideline on GVP was a key deliverable of the 2010 pharmacovigilance legislation.

Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States.

The guideline on GVP is divided into chapters that fall into two categories:

• modules covering major pharmacovigilance processes;

product- or population-specific considerations

5•Pharmacovigilance in the form of surveillance of antibiotic use is being done in 90% of the countries worldwide through the WHONET program developed by WHO. However, the data comes from a limited area of the globe. Data from every part of the world is required, so that there is geographical representation of every region. A major hurdle in quantifying the extent of antimicrobial resistance is the fact that there are several known microbes, that may turn out to be resistant to one or more of the several known antimicrobial agents. The global action plan initiated by WHO, if implemented successfully will definitely reduce AMR and will help in evaluating treatment interventions.